Reinforced biological construct and method of reinforcing biological construct

ABSTRACT

A reinforced graft construct for repairing a tendon or ligament formed by inserting a piece of material, such as suture, through the graft lengthwise. The material may be inserted along only a portion of the graft or along the entire graft. The material may be a reinforcement (reinforcing) material such as suture, tape, weave, or mesh passed lengthwise through the graft (for example, along the center of the graft). The ends of the graft may be whipstiched to provide additional fixation when implanted. The material may be bioabsorbable such that it will resorb away after a period of time in the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 13/207,563,filed Aug. 11, 2011, which claims the benefit of U.S. ProvisionalApplication No. 61/376,109, filed Aug. 23, 2010, the disclosures ofwhich are incorporated by reference in their entirety herein.

FIELD OF THE INVENTION

The present invention relates to the field of surgery and, moreparticularly, to a construct for tendon or ligament repair orreconstruction, to a method of ligament or tendon repair orreconstruction, and also to a method of graft preparation for attachmentto bone.

BACKGROUND OF THE INVENTION

Reconstructive surgeries, particularly tendon or ligamentreconstruction, are well-known in the art. In general, these methodsinvolve repairing a tendon or ligament by stitching it together or usinga graft to repair the tendon or ligament. ACL repairs involve drilling atunnel through the tibia, drilling a closed tunnel (socket) into thefemur, inserting a substitute ACL graft into the tunnels, and securingthe graft to the walls of the tibial and femoral tunnels usinginterference screws or the like. Tensioning and fixation of the graft inthe tunnel is important for optimal results. A need exists for a methodof re-attachment of soft tissue to bone which allows the graft to besecurely placed in the bone tunnel and properly tensioned until naturalreattachment occurs.

Repairs of other tendons or ligaments, such as the Achilles tendon,require trying to reattach the torn pieces of the existing tendon backtogether. This can be difficult to accomplish when the tendon ends areweaker because of the tear. The stitches can rip through the tendon atthe repair site. A need exists for reinforcing the torn tendon at therepair site.

BRIEF SUMMARY OF THE INVENTION

The present invention provides a construct and method for attachment oftendon/ligament/graft to bone using a reinforced tendon/ligament/graftconstruct for repair or reconstruction. The reinforced constructincludes a tendon/ligament/graft with a material such as suture, tape,weave, or mesh passed lengthwise through the center of the constructwith the ends of the construct being whipstiched to provide additionalfixation when implanted. The material may be absorbable ornon-absorbable.

Other features and advantages of the present invention will becomeapparent from the following description of the invention which refers tothe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a reinforced assembly including a reinforcedcontinuous graft loop construct with an overlapped whipstiched sectionaccording to an embodiment of the present invention and with twofixation members for ACL reconstruction.

FIGS. 2A-2G illustrate subsequent steps for making the reinforcedcontinuous graft loop of FIG. 1.

FIG. 3 illustrates just the reinforced continuous graft loop of theconstruct of FIG. 1 (with the ends of the graft stitched together in anoverlapping manner).

FIG. 4 illustrates an alternate embodiment of a reinforced continuousgraft loop of the present invention, where the ends of the graft arestitched together in a non-overlapping manner.

FIG. 5A illustrates another view of the reinforced assembly of FIG. 1with one of the fixation devices attached to the tibia.

FIG. 5B illustrates an alternate embodiment of a reinforced assembly ofthe present invention with a reinforced continuous graft loop constructand a cross-pin fixation device.

FIG. 6 illustrates an alternate embodiment of a reinforced continuousgraft loop where only the whipstitched portion of the loop isreinforced.

FIG. 7 illustrates an alternate embodiment of a reinforced continuousgraft loop having two reinforced whipstitched sections separated by asmooth unstitched section.

FIGS. 8A-D illustrate a method of preparing the reinforced continuousgraft loop of FIG. 7.

FIGS. 9A-C illustrate a method of reinforcing a torn ligament or tendonin-situ, and according to another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides techniques and constructs for ligament ortendon repair or graft preparation that provide simpler reconstructiontechniques and improved graft fixation.

According to the techniques of the present invention, a reinforcedconstruct (for example, a reinforced graft, ligament or tendonconstruct) for repairing a tendon or ligament is formed by inserting apiece of material (such as suture) through the graft lengthwise. Thematerial may be inserted along only a portion of the graft or along theentire graft. For example, the material may be a reinforcement(reinforcing) material such as suture, tape, weave, or mesh passedlengthwise through the graft (for example, through the center of thegraft and along the longitudinal axis of the graft). The ends of thegraft may be whipstiched to provide additional fixation when implanted.

The reinforcing material may be bioabsorbable such that it will resorbaway after a period of time in the body. The ends of the graft may bewhipstitched as is known in the art to provide for added strength of thegraft for better fixation.

The reinforced graft construct may also be formed into a loop with atleast one fixation device attached to the reinforced graft construct(for example, with a fixation device on each end) for various repairssuch as ACL repairs.

FIG. 1 illustrates a final reinforced assembly 500 comprising areinforced loop construct 100 of the present invention with two fixationdevices 200 a, 200 b attached thereto. As detailed below, the reinforcedloop construct 100 is formed of a loop of biological construct 10 (suchas graft, ligament or tendon) with ends 12, 14 attached together andwith a reinforcement material 30 extending longitudinally along at leasta portion of the length of the biological construct 10. At least onefixation device may be optionally attached to the reinforced loopconstruct 100. As detailed below, the ends 12, 14 may be attached(brought together) in an overlapping or non-overlapping manner and theymay be stitched to form additional reinforced sections.

Although the embodiments below will be described with reference toparticular materials and compositions such as graft 10 or suture 30, itmust be understood that the invention is not limited to these particularexemplary embodiments and encompasses any biological construct (such asgraft, tendon, ligament, or combinations thereof) that can be reinforcedwith any reinforcement material (such as suture, tape, mesh, orcombinations thereof).

An exemplary method of forming the reinforced loop construct 100(reinforced graft construct 100) of FIG. 1 is detailed below withreference to FIGS. 2A-2G.

FIG. 2A illustrates biological construct 10 (such as graft, ligament ortendon 10) secured in a prep-station 55 with an exemplary nitinolpassing wire 20 inserted therethrough. Biological construct 10 having afirst end 12 and a second end 14 is secured lengthwise to prep-station55. A nitinol passing wire 20 is inserted into one end of biologicalconstruct 10. A length of reinforcement material 30 (suture or tape 30),such as Fiberwire® or FiberTape® manufactured by Arthrex, Inc. Naples,Fla. is attached to the passing wire 20.

FIG. 2B illustrates the nitinol wire pulling the tape 30 (FiberTape® 30)through the biological construct 10. The passing wire 20 is pulledthrough the biological construct 10 to the second end 14. As the passingwire 20 travels through the biological construct, the suture 30 followsuntil the passing wire has passed completely through the biologicalconstruct leaving only the suture 30 extending from the first end 12 tothe second end 14 to form reinforced biological construct 11 (i.e.,tendon 10 reinforced with suture or tape 30).

FIG. 2C: In one embodiment, the biological construct 10 may be used foran arthroscopic repair such as ACL repair. A variety of fixation devices200 a, 200 b for the tibia and/or femur may be inserted onto thereinforced biological construct 11 (or attached to it) for ACL repairwith fixation at both ends (and prior to the loop formation). Examplesof fixation devices include a loop with a button (such as theRetroButton manufactured by Arthrex Inc.) or an adjustable loop withbutton (such as the ACL Tightrope manufactured by Arthrex Inc.). FIG. 2Cillustrates a RetroButton 200 a and an ACL Tightrope 200 b passed overthe reinforced biological construct 11 and prior to the loop formation.

FIG. 2D: The reinforced biological construct 11 is doubled over so thatthe first end 12 and the second end 14 overlap and form a reinforcedloop 11 a. The first and second ends 12, 14 are stitched together usinga needle 40 and suture 50 to whipstitch through the biological construct10 and the suture or tape 30 in the overlapping section 16, to createreinforced loop construct 100 (reinforced graft, ligament or tendon loopconstruct 100). FIG. 2D illustrates an exemplary #2 Fiberwire® 50 with atapered needle 40 used to whipstitch the overlapping section.

FIGS. 2E-F: The whipstitching continues (FIG. 2E) and is completed witha knot (for example, a six-thrown surgeon's knot shown in FIG. 2F) tocomplete the reinforced loop construct 100.

FIG. 2G: Once the whipstitching of the reinforced graft loop construct100 is completed, the reinforced assembly 500 is pre-tensioned to 20pounds for use in ACL repair. Depending on the type of repair theconstruct is being used for will determine the amount of pre-tensioning,which may be up to 50 pounds.

Although the above method was described using whipstitching, any type ofsuturing/stitching that would attach the first and second ends of thebiological construct 10 (tendon 10) together could be used.Additionally, the suture that is passed lengthwise through thebiological construct 10 may be an absorbable suture that would resorbaway after a length of time in the body.

FIG. 3 illustrates another view of reinforced loop construct 100 of thepresent invention including a loop of reinforced biological construct 11but without any fixation devices attached. This type of reinforced graftloop construct could be used as shown in FIG. 5B with a transfix orcross-pin type fixation device 300. FIG. 3 illustrates looped reinforcedconstruct 100 formed in an overlapping manner (i.e., with the two ends12, 14 of the reinforced construct brought together by overlapping eachother and then stitched together). The biological material 10 (forexample, tendon, graft, ligament) is reinforced with a reinforcingmaterial 30 such as suture, Fiberwire®, FiberTape®, absorbable suture,tape or any other material or combination of such materials to formreinforced biological construct 11. Once the ends 12, 14 of thereinforced construct 11 are brought together in an overlapping manner,stitching such as whipstitching or other securing stitch with suturesuch as #2 Fiberwire®, for example, may be conducted as detailed abovewith reference to FIGS. 2A-2G to form stitched loop region 16. Thereinforcement suture may be tied to create additional reinforcement.

In another alternate embodiment of the present invention as illustratedin FIG. 4, the first and second ends 12, 14 of the biological construct10 may be attached without overlapping to form reinforced loop construct110. A suture or tape 30 is still inserted longitudinally along thebiological construct 10 (i.e., tendon 10) prior to forming the loop 11a, and to form reinforced biological construct 11. Stitching is done oneach of the ends 12, 14 through the longitudinal suture or tape 30 tocreate reinforced sections 12 a, 14 a at each end 12, 14 which are thenstitched together at the ends instead of overlapping (i.e., the mostproximal and most distal ends of the reinforced biological construct 11are brought together and adjacent to each other by suturing or stitchingto form stitched region 15). The reinforcing suture 30 may be tied tocreate additional reinforcement.

FIG. 5A illustrates another view of the reinforced assembly 500 of FIG.1 (comprising reinforced loop construct 100 and two fixation devices 200a, 200 b attached thereto or inserted onto it) but with fixation device200 b secured to tibia 88, in a method of ACL repair with fixation atboth ends. Fixation device 200 a may be secured to the femur. At leastone of the fixation devices 200 a, 200 b may be a RetroButton® or otherbutton with a suture loop for attachment to the femoral side, or a anadjustable loop with button such as an ACL Tightrope® (or otheradjustable button and suture construct), for the tibial and/or femoralside fixation and passed over the graft.

FIG. 5B illustrates a reinforced assembly 600 with reinforced loopconstruct 100 used with a transfix or cross-pin type fixation device 300(or other rigid pin-type fixation device). A fixation device 200 b suchas a RetroButton®, ACL Tightrope® or other suture loop/button constructmay be attached to the reinforced loop construct 100 to secureattachment to the tibial side.

An alternate method of constructing reinforced loop construct 120 ofFIG. 6 follows the steps outlined in FIGS. 2A-2G, however, instead ofinserting the reinforcement material 30 (suture or tape 30) through theentire biological construct 10 (graft, ligament or tendon 10)lengthwise, a small needle with the suture or tape is passed lengthwisethrough only a portion of the biological construct 10 on the first end12 and the second end 14, preferably the end portions of the biologicalconstruct 10 (tendon 10) that will overlap. Whipstitching (with a suturesuch as #2 Fiberwire®) is conducted through the section 16 containingthe lengthwise suture or tape 30 to attach the overlapping ends 12, 14of the graft 10 to form stitched/sutured area of the reinforced loopconstruct 120. In this embodiment shown in FIG. 6, only the ends 12, 14of the graft loop are reinforced (with reinforced suture or tape 30 suchas FiberTape or absorbable tape material inserted only through the ends12, 14 of the tendon 10), and not the whole length of the tendon (i.e.,not the tendon portion extending between the two ends 12, 14).

In the specific embodiment shown in FIG. 6, the reinforced stitchedregion 16 contains two overlapped ends of the reinforced biologicalconstruct with two sections of reinforcement material 30 (suture or tape30) each of the two sections being passed through a respective one ofthe two ends (to form two reinforced ends), and further with the tworeinforced ends sutured/stitched together to form stitched/sutured area50. However, the invention also contemplates embodiments wherein thereinforced stitched region contains two overlapped ends of thereinforced biological construct with only one section of reinforcementmaterial 30 (i.e., only one section of suture or tape 30) passed throughonly one of the two ends, and further with the ends sutured/stitchedtogether. The length L1 of each of the ends 12, 14 with reinforcementmaterial 30 may be about ⅕ to about ¼ of the total length L of thebiological construct 10.

Reference is now made to FIG. 7. In an alternate method of constructinga reinforced loop construct 130, the construct may be separated intothree zones, including two reinforced areas 16 a, 16 b (for example, twowhipstitched areas 16 a, 16 b of biological construct) and one zone 18of bare biological construct (tendon) (smooth unstitched portion)between the other two zones. This construct may be beneficial in anall-inside procedure (patient specific) such as an all-inside ACLreconstruction when placing the whipstitched zones of the construct intobone sockets, such as the femoral and tibial sockets, while theunstitched zone can be in contact with the articulating surfaces of thebone. This prevents irritation between the articulating surfaces due tothe presence of stitching. FIG. 7 illustrates this embodiment where thereinforced whipstitched sections 16 a, 16 b are separated by anunstitched section 18.

Each of the reinforced whipstitched sections 16 a, 16 b contains twosections of reinforcement material 30 (suture or tape 30), each sectionof reinforcement material 30 being passed through a respective sectionof one of the two ends 12, 14. Each of the reinforced whipstitchedsections 16 a, 16 b also contains a stitched (sutured) area 50 formedwith a flexible material such as suture. Reinforcement material 30(suture or tape 30) may be inserted along the length of each end andcentered with respect to the longitudinal axis of the biologicalconstruct 10 (tendon 10). The final reinforced construct 130 includesfour sections of reinforcement material 30 (suture or tape 30) insertedalong the length of two regions of ends 12, 14 that are brought together(in an overlapping manner) and stitched with additional flexiblematerial such as suture.

The two reinforced whipstitched sections 16 a, 16 b may have the samelength or different lengths as determined by the depth of the socketscreated in the reconstruction procedure. This construct allows foradjustability for each patient based on the actual socket size createdduring the surgery. In an exemplary embodiment only, length L1 of thereinforced whipstitched sections 16 a, 16 b may be about equal to lengthL2 of the bare section 18 (smooth unstitched section 18) and about ⅓ toabout ¼ of the total length L of the reinforced construct 130. In anexemplary embodiment only, length L1 may be about 20 mm and length L2may be about 20-30 mm, while length L may be about 90-120 mm.

FIGS. 8A-8D illustrate exemplary steps of the method of creating theconstruct of FIG. 7.

FIG. 8A: The reinforcing material 30 (FiberTape®) is passed lengthwiseinto and out of the free end of the tendon, and then inserted into theportion of the tendon loop that is alongside the free end, creating a“U-shape” with the reinforcing material 30. A shown in FIG. 8A, thesecond zone of reinforced whipstitching is created by insertingreinforcing material 30 (suture or tape 30) through one end 12 of thebiological construct 10 (tendon 10) lengthwise to the end of the tendonand then inserting the same reinforcing material 30 (suture or tape 30)into the overlapping section of the tendon lengthwise a distancedetermined to correlate to the depth of the socket or tunnel. Thedistance may be in the range of 20-30 mm. The reinforcing material 30(suture 30) forms a U-shape in the tendon.

FIG. 8B: A single stand of flexible material (for example, #2Fiberwire®) is used to begin the whipstitching. It is not necessary topierce the reinforcing material 30 (FiberTape® 30) with every pass,although it is helpful to use the visible portions of the FiberTape® forthe first several stitches. In FIG. 8B, another flexible strand 50(suture 50) is used to whipstitch the overlapping sections of the tendontogether through the reinforcing material 30 (suture 30) to create azone of reinforced whipstitching 16 b.

FIG. 8C: Whipstitching is continued down the opposite side of the graft.

FIG. 8D: The free ends of the Fiberwire® are knotted to secure thestitch. FIG. 8D illustrates the final construct with reinforcedwhipstitched zones 16 a, 16 b and the stitch-free zone 18 (smoothunstitched section 18).

An exemplary technique for repairing a tendon or ligament that is tornwithin the body without using a graft includes reinforcing the torntendon or ligament within the body and at the injury repair site (i.e.,in-situ). One method for reinforcing torn tendon 10 is illustrated inFIGS. 9A-C. FIG. 9A shows inserting a reinforcement material 30 (forexample, a suture type material 30) in a direction about parallel toeach torn edge 10 a, 10 b of the torn tendon 10 and a short distance “d”of about 1-4 mm from the edge of the tendon 10. In this embodiment, thereinforcement material 30 is not inserted along the longitudinal axis ofthe construct (i.e., in a direction parallel to the longitudinal axis)but rather in a direction about perpendicular to the longitudinal axisof the construct.

Another length of reinforcement material 40 (for example, a suture orsimilar type material) is passed through the ends 10 a, 10 b of the torntendon 10 and also through the previously-inserted reinforcementmaterial 30 (i.e., suture material 30). FIG. 9B illustrates a mattressstitch being applied through the reinforced end of the torn tendon. Thesame steps are repeated on the other torn end of the tendon.

FIG. 9C illustrates the two reinforced torn ends 10 a, 10 b of thetendon stitched back together in stitched reinforced area 16 to completethe repair and form reinforced tendon construct 140.

Although the present invention has been described in connection withpreferred embodiments, many modifications and variations will becomeapparent to those skilled in the art. While preferred embodiments of theinvention have been described and illustrated above, it should beunderstood that these are exemplary of the invention and are not to beconsidered as limiting. Accordingly, the invention is not to beconsidered as limited by the foregoing description.

What is claimed is:
 1. A graft tendon, comprising: a first free tendonend and a second free tendon end, the first and second free tendon endspositioned longitudinally in parallel to one another, wherein the firstfree tendon end and the second free tendon end are located at anopposite end of the graft tendon from a folded portion of the grafttendon; a whipstitched pattern securing together the first and secondfree tendon ends, thereby forming a stitched end portion that abuts anunstitched middle portion, the whipstitched pattern comprising aplurality of sutures that originate at the first and second free tendonends and progress toward the unstitched middle portion; a fixationdevice; and comprising a reinforcement material passed lengthwisethrough at least a portion of the graft tendon and extending outwardlyfrom an end of the graft tendon.
 2. The graft tendon as recited in claim1, comprising a second fixation device, and both the fixation device andthe second fixation device are connected to the graft tendon.
 3. Thegraft tendon as recited in claim 1, wherein the fixation device is abutton and loop construct.
 4. The graft tendon as recited in claim 1,wherein the fixation device is a button and adjustable loop construct.5. The graft tendon as recited in claim 1, wherein the fixation deviceis an interference screw.
 6. The graft tendon as recited in claim 1,wherein the whipstitched pattern includes a knot for securing togetherthe first and second free tendon ends.
 7. The graft tendon as recited inclaim 1, wherein the first free tendon end and the second free tendonend overlap one another.
 8. The graft tendon as recited in claim 1,wherein the plurality of sutures reinforce the first and second freetendon ends.
 9. The graft tendon as recited in claim 1, wherein at leasta portion of the plurality of sutures extend in a direction aboutperpendicular to a longitudinal axis of the first free tendon end andthe second free tendon end.
 10. The graft tendon as recited in claim 1,wherein the graft tendon is a folded graft tendon.
 11. The graft tendonas recited in claim 1, wherein the graft tendon is configured in a loop.12. The graft tendon as recited in claim 1, wherein the first freetendon end and the second free tendon end are part of a single tendonstrand.
 13. The graft tendon as recited in claim 12, wherein the singletendon strand is folded to position the first free tendon end inparallel with the second free tendon end.
 14. A graft tendon assembly,comprising: a graft tendon having a single tendon strand that includes afirst free tendon end and a second free tendon end positionedlongitudinally in parallel with the first free tendon end, wherein thefirst free tendon end and the second free tendon end are located on anopposite end of the graft tendon from a folded portion of the grafttendon; a whipstitched pattern securing together the first and secondfree tendon ends, thereby forming a stitched end portion that abuts anunstitched middle portion of the graft tendon, the whipstitched patterncomprising a plurality of suture stitches that originate at the firstand second free tendon ends and progress toward the unstitched middleportion; a button; a flexible material connecting the graft tendon tothe button; and comprising a reinforcement material passed lengthwisethrough at least a portion of the graft tendon and extending outwardlyfrom an end of the graft tendon.
 15. The graft tendon assembly asrecited in claim 4, wherein the reinforcement material that is passedlengthwise through the portion is located between a first exteriorsurface of the first free tendon end and a second exterior surface ofthe second free tendon end.
 16. The graft tendon assembly as recited inclaim 14, wherein the stitched end portion includes a first length thatis less than a second length of the unstitched middle portion.